MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL WWD; PISTON SYRINGE

Model Number	301997
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that 5 syringes 10ml ll wwd were found with cracked plungers before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "during mfg process at togo medikit, cracked plunger product was confirmed.".
Additional Manufacturer Narrative
H.6.Investigation: six photos and five loose 10ml syringes were received and evaluated.It was observed four of the syringes had similar damage between the 6ml and 10ml grad lines.The damaged appeared to be circular in shape with surface scrapes across the barrel and a significant indentation.The plunger rods also contained a cracked or broken rib in the same location.Two of the syringes had the damage inside the grad lines and two of the syringes had damage outside the grad lines.One of the syringes only had a small amount of damage present on one of the retaining rings of the plunger rod with no other damage present.The damage on all five of the syringes was rejectable per product specification.A potential root cause for the damage defect is associated with the assembly process.Batch/lot information is required to make corrective action determinations.No corrective actions are necessary at this time.H3 other text : see h.10.
Event or Problem Description
It was reported that 5 syringes 10ml ll wwd were found with cracked plungers before use.The following information was provided by the initial reporter, translated from japanese to english: "during mfg process at togo medikit, cracked plunger product was confirmed.".

• Brand Name: SYRINGE 10ML LL WWD
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10111435
• Report Number: 1213809-2020-00354
• Device Sequence Number: 19427898
• Product Code: FMF
• UDI-Device Identifier: 30382903019978
• UDI-Public: 30382903019978
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 301997
• Device Catalogue Number: 301997
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other